Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008347275

FEI Number

3008347275

Entity Name

Dental Direkt GmbH

City/State/Country

Spenge North Rhine-Westphalia, DE

Establishment Address

Industriezentrum 106-108, Spenge North Rhine-Westphalia 32139, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dental Direkt GmbH (Owner Number: 10032224)

Owner / Operator Contact Address

Industriezentrum 106-108, Spenge, DE-NW 32139, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241579

PMA Number

N/A

All Registered Proprietary Names

DD contrast Nacera Pearl Shaded 16+2 DD poly Y ML DD cube ONE DD cubeX² ML DD Pro Shade Z DD Basic Shade DD Art Elements DD Pro Shade C DD cubeX² DD cube ONE ML DD Scanbody 2 DD Ti-Base 2CUT DD Ti-Base 2CUT noLock DD Prefab DD Ti-Base 2CUT DD Ti-Base 2CUT noLock DD base P HI DD Bio Splint P HI DD Bio ZX² color DD Bio ZX² DD Bio ZW iso i700 DD cubeY HL Nacera Pearl Natural

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2020-04-22
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2024-05-27
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2025-02-17
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2017-08-07
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2015-04-01
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2019-02-18
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2023-11-02
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-05-02
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-04-26
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2023-06-27
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2023-06-27
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2015-07-28
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2019-04-15
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2024-09-09

Official Correspondent

No official correspondent registered.

US Agent Details

Franz Menean Business: MEDAGENT, Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

Dental Direkt GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Z-0021-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008347275. Last updated year: 2026. Please use registration number 3008347275 when referencing this establishment in official correspondence.